Pulmicort Respules(budesonide inhalation suspension) vs Singulair, children
Study identifier:DX-RES-2103
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An evaluation of the effectiveness of Pulmicort Respules (Budesonide inhalation Suspension) versus SINGULAIR (montelukast sodium) in children 2-8 years old with asthma requiring controller therapy.
Medical condition
asthma
Phase
Phase 4
Healthy volunteers
No
Study drug
Budesonide inhalation suspension, Montelukast Sodium
Sex
All
Actual Enrollment
380
Study type
Interventional
Age
2 Years - 8 Years
Date
Study Start Date: 01 Oct 2002
Primary Completion Date: 01 Feb 2005
Study Completion Date: 01 Feb 2005
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Budesonide inhalation suspension | Drug: Budesonide inhalation suspension 0.5mg Other Name: Pulmicort Respules |
| Active Comparator: 2 Montelukast sodium | Drug: Montelukast Sodium 4mg or 5mg Other Name: SINGULAR |
Contacts
Investigators
Principal Investigator
Bertil Andersson
AstraZeneca
